NN7769-7602 FRONTIER AHA: To Investigate the efficacy and safety of denecimig (Mim8) in AHA
Research type
Research Study
Full title
A multinational, open-label study to investigate efficacy and safety of denecimig (Mim8) in adults with acquired haemophilia A
IRAS ID
1013693
Contact name
Clinical Transparency
Contact email
Sponsor organisation
Novo Nordisk A/S
Clinicaltrials.gov Identifier
Research summary
Acquired haemophilia A (AHA) is a rare disease where the body’s immune system mistakenly attacks a protein called factor VIII in the blood. Factor VIII is needed to make the blood clot in case of an injury. The disease usually affects older adults, both men and women. People with this disease can have unexpected bleeding that can be severe and even life-threatening.
About 60 adults with AHA will join this global study, and about 3 from the UK.
This open-label, single-arm study treats all participants denecimig. The main phase is 12 weeks, when denecimig is injected monthly without immune-suppressing medicine. If further treatment is needed, an extension phase of up to 40 weeks allows continued monthly, weekly or biweekly denecimig injections; and immune-suppressing medicine may be added if needed. Participants are monitored for about 21 weeks after the end of treatment visit or early discontinuation visit, whichever is first.
Participants must be at least 18 years old, have a diagnosis of AHA, and had a bleed that needed treatment within 2 weeks before entering the study, and be able to follow instructions and seek care as needed.
Once diagnosis and eligibility have been confirmed, denecimig treatment begins. During the study, doctors will perform physical exams, blood pressure and heart rate checks, and blood tests. They will check for infections, allergic reactions, and other medications being used. Bleeds are managed with standard emergency care.
Novo Nordisk staff and monitors will review study data at the clinic to ensure accuracy. Participant information will remain confidential.
This study aims to enhance treatment for people with AHA. Participants may benefit from denecimig and medical checks but could also experience side effects. Common side effects from denecimig injections include skin problems where the injection is given, and allergic reactions. Participants may also have slight pain and skin problems from blood sampling.
REC name
London - West London & GTAC Research Ethics Committee
REC reference
26/LO/0233
Date of REC Opinion
10 Jun 2026
REC opinion
Further Information Favourable Opinion